According to Chinese news, the Chinese Ministry of Health announced Friday that despite its “joint investigation” with U.S. drug authorities, it could still not conclude that the multiple U.S. deaths were a result of contaminated heparin sold by Baxter, who bought the raw ingredient supplied by SPL from its facility in China, SPL Changzhou. (07/18/08 China View News: “Cause of deaths still in doubt after Sino-U.S. Investigation on Blood Thinner.”)

As you may recall, China’s drug agency reported the same inability to link the reported deaths in May of this year. (See our May 7, 2008 Blog: China Points the Finger at Baxter and the FDA.”) At that time, the inability of China and the U.S. FDA to cooperate was evident. Chinese officials claimed that Baxter and the FDA failed to provide them with medical records, medical histories, and information on Baxter's manufacturing practices. The Chinese also complained that they had not been given samples of the contaminated product. The FDA complained that it was not provided records from Changzhou Techpool Pharmaceutical Co. (“CZTP”), a company who supplied SPL Changzhou with raw heparin and may have been a source for the contaminant.

U.S. researchers confirmed the link between the adverse events, including death, and the contaminant, OSCS, since at least April 23, 2008, when the results of the first study were reported in an article published online by the New England Journal of Medicine entitled, “Contaminated Heparin Associated with Adverse Clinical Events and Activation of the Contact System.” As reported on the FDA website, “The contaminant activates chemicals in the body called enzymes. These enzymes cause the body to make inflammatory mediators (chemicals that are released by immune cells). Inflammatory mediators can lead to some of the symptoms such as low blood pressure, abdominal symptoms and shortness of breath.” (FDA: Questions and Answers re Heparin.)

It seems, therefore, that the two agencies are still failing to cooperate and exchange pertinent information. Maybe someone should give the Chinese Ministry of Health a copy of the New England Journal of Medicine article.

Labels: Baxter, Baxter Heparin, Changzhou, China, Chinese, FDA, Heparin, heparin lawsuit, heparin lawyer, MDL, nightline, OSCS, over sulfated chondroitin sulfate, oversulfated chondroitin sulfate, SPL